Alimta(R) Showed Advances over Taxotere(R) in Second-Line Non-Small Cell Lung Cancer Study
May 03 2004 - 10:02AM
PR Newswire (US)
Alimta(R) Showed Advances over Taxotere(R) in Second-Line Non-Small
Cell Lung Cancer Study INDIANAPOLIS, May 3 /PRNewswire-FirstCall/
-- In a recent study, Lilly's drug Alimta(R) (pemetrexed)
demonstrated a similar patient survival rate, but with an improved
safety profile, when compared to Taxotere(R) (docetaxel), the
current standard of care for second-line non-small cell lung
cancer. The research findings of the largest head-to-head Phase III
trial ever reported to date in second-line non-small cell lung
cancer were reported in the May 1 issue of the Journal of Clinical
Oncology(1), a peer-reviewed journal. Alimta, in combination with
cisplatin, was recently approved by the FDA for use in the
treatment of malignant pleural mesothelioma, a cancer often
associated with asbestos exposure. Currently, Taxotere is the only
drug approved in the U.S. to treat patients with non-small cell
lung cancer in the second line setting. While the drug extends the
average patient's life by a few months when compared to best
supportive care, it is associated with several side effects,
including hair loss and blood-related toxicities, including
neutropenia, a lowering of the white blood cell count that can
cause infections and fever, thus requiring hospitalization. The new
findings show that Alimta, which can be administered in 10 to 15
minute infusions once every three weeks, displayed a survival rate
comparable to that of Taxotere (median survival was 8.3 months vs.
7.9 months respectively), but with fewer serious side effects.
"Alimta clearly had fewer drug-related hematological side effects,
which resulted in fewer hospitalizations," said Nasser Hanna, M.D.,
lead author of the study and assistant professor, Indiana
University School of Medicine and member of the Indiana University
Cancer Center. "So in short, Alimta is better tolerated, it's
convenient to administer and it's equally as effective as
Taxotere." Patients on Alimta did show an increased transient
elevation in the liver enzyme, Alanine Transaminase (ALT) said
Hanna. Lilly has submitted a New Drug Application to the Food and
Drug Administration for the use of Alimta in the second-line
treatment of non-small cell lung cancer. Lilly anticipates a
regulatory decision by the fourth quarter. Lilly has also submitted
a dual European submission, with the first part for Alimta,
combined with cisplatin, in the treatment of malignant pleural
mesothelioma and the second for Alimta as a single-agent in the
second-line treatment of non-small cell lung cancer. "We commend
the scientists in this study for their commitment to conducting
quality research in an effort to support patients and physicians
who are affected by this devastating disease," said Paolo Paoletti,
M.D., vice-president of clinical research, oncology products, Eli
Lilly and Company. "Importantly, this was a study in which Alimta
was compared to the standard of care in the treatment of
second-line non-small cell lung cancer and the results were similar
efficacy and less blood-related toxicity for Alimta." Study Design
The Phase III global study involved 571 randomized patients whose
non- small cell lung cancer advanced beyond the first chemotherapy
regimen. Among the patients enrolled in this study, 283 received
Taxotere (75 mg/m2 on day one of a 21-day cycle; one-hour infusion)
and 288 received Alimta (500 mg/m2 on day one of a 21-day cycle;
10-minute infusion; supplemented with vitamin B12 and folic acid).
The primary endpoint was overall survival and secondary endpoints
included toxicity, response rate, and progression-free survival.
Key study findings are as follows: Alimta (n=265) Taxotere (n=276)
p-value Median Survival Time 8.3 months 7.9 months NS (non
statistically significant) Overall Response Rates 9.1 percent 8.8
percent NS (non statistically significant) Grade 3 or 4 Neutropenia
5.3 percent 40.2 percent